NCT00499447已完成不适用
A Phase II Study of Radiofrequency Ablation Combined With External Beam Radiation Therapy for Patients With Medically Inoperable Non-Small Cell Lung Cancer (Stage Ia and Select Ib) and the Predictive Value of Positron Emission Tomography
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Two Year Progression Free Survival Rate
研究概览
简要总结
RATIONALE: Radiofrequency ablation uses a high-frequency electric current to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiofrequency ablation together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving radiofrequency ablation together with external-beam radiation therapy works in treating patients with stage I non-small cell lung cancer that cannot be removed by surgery.
详细描述
OBJECTIVES:
Primary
- To determine progession free survivial rates in patients with inoperable stage IA and select stage IB non-small cell lung cancer treated with external-beam radiation therapy and radiofrequency ablation (RFA).
Secondary
- To determine the acute and late toxicity of combining RFA with external-beam radiation therapy.
- To determine the patterns of failure at time of first relapse.
- To determine the rate of overall survival at 1 and 2 years after treatment.
- To evaluate the ability of peak standard uptake value (SUV) and max SUV obtained prior to RFA to predict local control and time to progression.
- To measure post RFA/simulation (treatment planning) PET max and peak SUV's and correlate this data with local control at 1 and 2 years.
- To evaluate the ability of peak and max SUV's for fludeoxyglucose F 18 obtained shortly after radiotherapy (post-treatment) to predict local control and time to progression.
- To evaluate PET-CT data and its utility in guiding radiation therapy treatment planning.
- To explore the use of dual time point imaging PET data obtained to predict local control and also to differentiate between recurrence versus inflammation when applicable.
- To assess physical function as a prognostic measure, and to determine the impact of treatment on physical function.
- To evaluate the impact of treatment on generic and disease-specific quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed non-small cell lung cancer
- •Cytology or biopsy-proven disease
- •Stage IA (T1N0M0) or select stage IB (T2N0M0 because of visceral pleural involvement or size ≥ 3.0 cm)
- •Tumor size ≤ 3.5 cm
- •No bronchioloalveolar carcinoma
- •Node-negative patients will have hilar or mediastinal lymph nodes ≤ 1.5 cm and no clinically suspicious uptake on fludeoxyglucose F 18 (FDG)-PET in those areas
- •Patients with > 1.5 cm lymph nodes and clinically suspicious FDG-PET uptake will still be eligible if directed tissue biopsy or needle aspiration of abnormally identified area are negative for cancer
- •Patients with > 1.5 cm and < 2.0 cm lymph nodes and no clinically suspicious FDG-PET uptake in those areas will still be eligible
- •All patients are required to have been evaluated by a thoracic surgeon and have either refused surgery or been deemed medically inoperable due to comorbid conditions
- •CT images of the chest must be reviewed by an experienced interventional radiologist and the target lesion must be determined to be in a location where radiofrequency ablation is technically achievable based on the proximity of adjacent organs and structures
- •Any patient with suspected M1 disease based on pre-treatment PET-CT imaging should have biopsy if possible
- •If the biopsy is positive, the patient should be treated as per the clinician's preference off of this protocol
- •If the biopsy is negative and representative of the lesion in question then the patient may be treated as per this protocol
- •If the biopsy is non-diagnostic, consideration should be given to repeat biopsy
- •If the repeat biopsy remains non-diagnostic or a biopsy is not feasible than the patient will not be eligible for this protocol and should be treated per the clinician's preference
- •PATIENT CHARACTERISTICS:
- •Inclusion Criteria:
- •ECOG performance status 0-2
- •Women of childbearing potential must have a negative pregnancy test
- •Fertile women must use effective contraception
排除标准
- •History of prior malignancy within the past 2 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, T1N0 squamous cell carcinoma of the larynx, or localized prostate cancer with a current PSA level < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to study entry
- •Pregnant or lactating women
- •PRIOR CONCURRENT THERAPY:
- •Exclusion Criteria:
- •Previous chest radiation to the lung or mediastinum
- •Patients must not receive other concurrent anticancer therapies while on protocol including any of the following:
- •Radiotherapy
- •Radiofrequency ablation
- •Other antineoplastic interventional radiology techniques
- •Chemotherapy
- •Biological therapy
- •Vaccine therapy
- •Surgical treatment of nonmelanomatous skin cancer or ≤ T1 urothelial cell carcinoma allowed
研究组 & 干预措施
Radiofrequency Ablation with External Beam Radiation
Experimental
Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
干预措施: radiofrequency ablation (Procedure)
Radiofrequency Ablation with External Beam Radiation
Experimental
Radiofrequency Ablation (RFA)under computerized tomography guidance followed 3-4 weeks later with External Beam Radiation Therapy
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Two Year Progression Free Survival Rate
时间窗: 2 years
the number of patients surviving progression-free at two years.
次要结局
未报告次要终点
研究者
研究点 (1)
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